Darzalex 1800 mg per 15 ml 1800 Solution for injection 15ml Vial

Darzalex Faspro 1800 mg/15 ml Solution for Injection Overview

Darzalex Faspro 1800 mg/15 ml Solution for Injection is a critically important prescription medication indicated for the treatment of adult patients with multiple myeloma and light chain (AL) amyloidosis.

This advanced therapeutic targets CD38-positive cancer cells, playing a pivotal role in the management of these complex blood cancers.

Developed by Janssen Biotech, Inc., it represents a significant advancement in oncology, offering a targeted approach to disease control.

Benefits of Darzalex Faspro

Darzalex Faspro offers several key benefits for patients undergoing treatment for multiple myeloma and light chain amyloidosis:

• Targeted Action: Specifically targets the CD38 protein found on multiple myeloma cells and some AL amyloidosis cells, leading to direct cell death and immune-mediated anti-tumor effects.
• Broad Indications: Approved for use across various stages of multiple myeloma, including newly diagnosed and relapsed/refractory settings, as well as for light chain amyloidosis.
• Convenient Administration: Administered subcutaneously, which typically involves a shorter administration time compared to intravenous infusions of daratumumab, enhancing patient comfort and clinic efficiency.
• Improved Outcomes: Clinical studies have demonstrated its efficacy in improving response rates, progression-free survival, and overall survival in patients with these challenging conditions.
• Combination Therapy Potential: Can be used as a monotherapy or in combination with other standard treatments, providing flexibility in treatment regimens.

How to Use Darzalex Faspro

Darzalex Faspro is a prescription medication that must be administered by a healthcare professional in a medical setting. It is delivered via subcutaneous injection. The typical administration process involves:

1. Preparation: The healthcare professional will prepare the Darzalex Faspro solution according to sterile procedures.
2. Pre-medication: Patients typically receive pre-medications to reduce the risk of infusion-related reactions. These may include corticosteroids, antihistamines, and antipyretics.
3. Injection Site Selection: The injection is usually given in the abdomen, at least two inches from the navel, or in the thigh. Injection sites should be rotated.
4. Subcutaneous Administration: The healthcare professional will slowly inject the solution under the skin. The entire dose of 15 mL may be administered at one site or split into two separate injection sites.
5. Post-administration Monitoring: Patients will be monitored for any immediate reactions following the injection.

It is crucial to follow the schedule and dosage determined by your treating physician. Do not attempt to self-administer Darzalex Faspro.

Caution & Warnings

• Infusion-Related Reactions: Darzalex Faspro can cause injection-related reactions, which may be severe. Patients should be pre-medicated and monitored during and after administration.
• Myelosuppression: May cause decreases in white blood cell counts (neutropenia), red blood cell counts (anemia), and platelet counts (thrombocytopenia). Regular blood monitoring is essential.
• Infections: Patients may have an increased risk of infections, including viral, bacterial, and fungal infections. Report any signs of infection to your doctor.
• Hepatitis B Virus (HBV) Reactivation: HBV reactivation has been reported in patients treated with Darzalex. Screening for HBV should be performed before initiating treatment.
• Interference with Cross-Matching and Red Blood Cell Antibody Screening: Darzalex Faspro can interfere with indirect antiglobulin tests, making it difficult to detect some antibodies. Inform blood banks that you are receiving Darzalex Faspro.
• Embryo-Fetal Toxicity: Darzalex Faspro can cause fetal harm when administered to a pregnant woman. Women of reproductive potential should use effective contraception during and for 3 months after treatment.
• Immunogenicity: Patients may develop anti-daratumumab antibodies.
• Drug Interactions: Discuss all medications, including over-the-counter drugs and supplements, with your healthcare provider.

Ingredients

Active Ingredients:

• Daratumumab
• Hyaluronidase-fihj

Excipients:

• L-Histidine
• L-Histidine Monohydrochloride Monohydrate
• Methionine
• Polysorbate 20
• Sorbitol
• Sodium Chloride
• Water for Injection

Product Details

• Brand: Darzalex Faspro
• Manufacturer: Janssen Biotech, Inc.
• Dosage Form: Solution for Injection
• Strength: 1800 mg Daratumumab per 15 mL vial
• Active Ingredient: Daratumumab and Hyaluronidase-fihj
• Administration Route: Subcutaneous
• Primary Indication: Multiple Myeloma, Light Chain (AL) Amyloidosis
• Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze.